Health TrialsbyHealthPanel

18F-grazy-02 PET/CT of Granzyme B Expression for Monitoring Immunotherapy

ConditionCancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute

About this trial

This is an open-label PET/CT study to investigate the safety and clinical monitoring value of 18F-grazy-02 in patients with lymphoma or solid tumors receiving immunotherapy, including immune checkpoint inhibition and CAR-T cell therapy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-75 years old;

ECOG score 0 or 1 point;

Participants with suspected or confirmed non-small cell lung cancer or melanoma who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging.

Disqualifiers

Pregnant or nursing;

Severe hepatic or renal dysfunction;

Low WBC (less than 3 x 10^9/L);

Unable to comply with the PET/CT imaging procedures.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 18F-grazy-02

    Drug

    18F-grazy-02 PET/CT: after intravenous injection of 2.96-3.7 MBq/kg body weight of quality-controlled 18F-grazy-02 , a Total-body PET/CT uEXPLORER scanner will be applied.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: experimental 18F-grazy-02 PET/CT imagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of 18F-grazy-02-emergent Adverse Events

Any adverse events following the administration of the radiotracer will be monitored.

Time frame
1 year
2

Biodistribution of 18F-grazy-02 in participants

The distribution of 18F-grazy-02 in tumors and healthy tissues will be examined through PET/CT imaging.

Time frame
1 year

Secondary outcomes

1

Assessing 18F-grazy-02 PET for monitoring immunotherapy responses

Participants will be categorized into groups with high or low 18F-grazy-02 uptake in tumor lesions. Therapy efficacy of immunotherapy as assessed by RECIST 1.1 will be compared across these two groups.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Cancer Hospital & Institute

Lead sponsor

Source ClinicalTrials.gov
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